01 1Atul Bioscience Ltd
01 1CLIOQUINOL
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9078
Submission : 1991-04-20
Status : Inactive
Type : II
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A Enterum locorten manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enterum locorten, including repackagers and relabelers. The FDA regulates Enterum locorten manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enterum locorten API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Enterum locorten manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Enterum locorten supplier is an individual or a company that provides Enterum locorten active pharmaceutical ingredient (API) or Enterum locorten finished formulations upon request. The Enterum locorten suppliers may include Enterum locorten API manufacturers, exporters, distributors and traders.
click here to find a list of Enterum locorten suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Enterum locorten DMF (Drug Master File) is a document detailing the whole manufacturing process of Enterum locorten active pharmaceutical ingredient (API) in detail. Different forms of Enterum locorten DMFs exist exist since differing nations have different regulations, such as Enterum locorten USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Enterum locorten DMF submitted to regulatory agencies in the US is known as a USDMF. Enterum locorten USDMF includes data on Enterum locorten's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Enterum locorten USDMF is kept confidential to protect the manufacturer’s intellectual property.
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